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Study to Evaluate the Efficacy and Safety of Camrelizumab and Apatinib in Patients With GC/GEJC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04342910
Recruitment Status : Recruiting
First Posted : April 13, 2020
Last Update Posted : November 18, 2020
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

Brief Summary:
This is a study for participants with advanced gastric or gastroesophageal junction adenocarcinoma who have had tumor progression after first-line platinum-contained therapy. The primary study hypotheses are that camrelizumab (SHR-1210) combined with apatinib prolongs overall survival (OS) for participants with tumors that show positive programmed cell death ligand 1 (PD-L1) expression.

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: camrelizumab Drug: Apatinib Mesylate Drug: Paclitaxel Drug: Irinotecan Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 550 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Study of Camrelizumab (SHR-1210) Combined With Apatinib Versus Paclitaxel or Irinotecan in Participants With Advanced Gastric/Gastroesophageal Junction Adenocarcinoma Progressed After First-line Chemotherapy
Actual Study Start Date : September 21, 2020
Estimated Primary Completion Date : April 1, 2022
Estimated Study Completion Date : September 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: camrelizumab (SHR-1210) combined with apatinib
Participants will receive camrelizumab on Day 1 and Day 15 of each 28-day cycle and apatinib mg/day up to 2 years.
Drug: camrelizumab
200 mg intravenous (IV) camrelizumab on Day 1 and Day 15 of each 28-day cycle.
Other Name: SHR-1210

Drug: Apatinib Mesylate
250 mg qd

Active Comparator: Paclitaxel or Irinotecan
Participants receive paclitaxel on Days 1, 8, and 15 of each 28-day cycle, or irinotecan on Days 1 and 15 of each 28-day cycle.
Drug: Paclitaxel
80 mg/m^2 administered as IV infusion on Days 1, 8, and 15 of each 28-day cycle.

Drug: Irinotecan
180 mg/m^2 administered as IV infusion on Days 1, and 15 of each 28-day cycle.




Primary Outcome Measures :
  1. Overall Survival (OS) in PD-L1 Positive Participants. [ Time Frame: Up to 27 months ]
    OS was defined as the time from randomization to death due to any cause.


Secondary Outcome Measures :
  1. Overall Survival (OS) in All Participants. [ Time Frame: Up to 27 months ]
    OS was defined as the time from randomization to death due to any cause.

  2. Progression-free Survival (PFS) According to RECIST 1.1 base on investigator assessment in All Participants or in PD-L1 Positive Participants. [ Time Frame: Up to 27 months ]
    PFS was defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on investigator assessment, or death due to any cause, whichever occurs first.

  3. Time to Tumor Progression (TTP) According to RECIST 1.1 based on investigator assessment in All Participants or in PD-L1 Positive Participants. [ Time Frame: Up to 27 months ]
    TTP was defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on investigator assessment in All Participants.

  4. Time to Failure (TTF) in All Participants or in PD-L1 Positive Participants [ Time Frame: Up to 27 months ]
    TTF was defined as the time from randomization to treatment discontinuation caused by any reason.

  5. Objective Response Rate (ORR) According to RECIST 1.1 based on investigator assessment in All Participants or in PD-L1 Positive Participants. [ Time Frame: Up to 27 months ]
    ORR was defined as the percentage of the participants in the analysis population who had a confirmed CR or PR according to RECIST 1.1 based on investigator assessment.

  6. Duration of Response (DOR) According to RECIST 1.1 Based on investigator assessment in All Participants or in PD-L1 Positive Participants. [ Time Frame: Up to 27 months ]
    DOR was defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.

  7. Disease Control Rate (DCR) According to RECIST 1.1 based on investigator assessment in All Participants or in PD-L1 Positive Participants. [ Time Frame: Up to 27 months ]
    DCR was defined as the percentage of the participants in the analysis population who had a confirmed CR or PR or SD according to RECIST 1.1 based on investigator assessment.

  8. Time to Response (TTR) According to RECIST 1.1 based on investigator assessment in All Participants or in PD-L1 Positive Participants. [ Time Frame: Up to 27 months ]
    TTR was defined as the time from randomization to the first documented evidence of CR or PR.

  9. The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) as assessed by CTCAE v4.03. [ Time Frame: Up to 27 months ]
    The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) as assessed by CTCAE v4.03.

  10. Proportion of dose suspension, dose reduction or dose discontinuation caused by treatment-related toxicities. [ Time Frame: Up to 27 months ]
    Proportion of dose suspension, dose reduction or dose discontinuation caused by treatment-related toxicities.

  11. Proportion of anti-camrelizumab antibody (ADA) and neutralizing antibody (Nab) formed during the study from baseline [ Time Frame: Up to 27 months ]
    Proportion of anti-camrelizumab antibody (ADA) and neutralizing antibody (Nab) formed during the study from baseline

  12. Serum concentration of camrelizumab [ Time Frame: Up to 27 months ]
    Serum concentration of camrelizumab

  13. Plasma concentration of apatinib [ Time Frame: Up to 27 months ]
    plasma concentration of apatinib



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically- or cytologically-confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma.
  2. Confirmed metastatic or locally advanced, unresectable disease.
  3. Progression on or after prior first-line therapy containing any platinum/fluoropyrimidine or platinum/taxane doublet.
  4. Willing to provide tumor tissue for PD-L1 biomarker analysis.
  5. Human epidermal growth factor receptor 2 (HER-2/neu) status known and participants with HER2/neu positive tumors show documentation of previous treatment containing trastuzumab.
  6. ECOG performance status of 0 to 1.
  7. Life expectancy of more than 12 weeks.
  8. Signing the informed consent forms.
  9. Adequate bone marrow, liver and renal function.

Exclusion Criteria:

  1. Squamous cell or undifferentiated gastric cancer.
  2. Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
  3. Subjects with an active, known or suspected autoimmune disease. Patients with type I diabetes who are receiving a stable dose of insulin, hypothyroidism who only needs hormone replacement therapy, and skin diseases (such as eczema, vitiligo, or psoriasis) that do not require systemic treatment and do not have acute deterioration within 1 year before the screening period, are allowed.
  4. Clinically significant cardiovascular and cerebrovascular diseases.
  5. Subjects with high blood pressure who cannot be controlled well with antihypertensive drugs.
  6. Previous digestive tract bleeding history within 3 months or evident gastrointestinal bleeding tendency.
  7. Arterial / venous thrombosis events, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism, occurred within the first 6 months of randomization.
  8. Subjects who have previously received anti-PD-1 / PD-L1 monoclonal antibody, anti-CTLA-4 monoclonal antibody, and VEGFR small molecule inhibitor therapy.
  9. Prior systemic chemotherapy, radiotherapy and surgery within 4 weeks before the study drug administration, or any unresolved AEs > Common Terminology Criteria for Adverse Events (CTCAE) Grade 1.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04342910


Contacts
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Contact: Quanren Wang, Ph.D wangquanren@hrglobe.cn

Locations
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China
Affiliated Hospital, Academy of Military Medical Sciences Recruiting
Beijing, China
Contact: Jianming Xu, PhD         
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
Investigators
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Principal Investigator: Jianming Xu, Ph.D Affiliated Hospital, Academy of Military Medical Sciences
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Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT04342910    
Other Study ID Numbers: SHR-1210-III-316
First Posted: April 13, 2020    Key Record Dates
Last Update Posted: November 18, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Paclitaxel
Irinotecan
Apatinib
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Protein Kinase Inhibitors